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Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma (ELARA)

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ClinicalTrials.gov Identifier: NCT03568461
Recruitment Status : Active, not recruiting
First Posted : June 26, 2018
Last Update Posted : May 6, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE May 24, 2018
First Posted Date  ICMJE June 26, 2018
Last Update Posted Date May 6, 2022
Actual Study Start Date  ICMJE November 12, 2018
Actual Primary Completion Date November 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
Complete response rate (CRR) [ Time Frame: 2 years ]
CRR based on Lugano classification response criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
  • Overall response rate (ORR) [ Time Frame: 2 years ]
    ORR, including complete response (CR) and partial response (PR)
  • Duration of response (DOR) [ Time Frame: 2 years ]
    Time from achievement of CR or PR to relapse or death due to follicular lymphoma
  • Progression free survival (PFS) [ Time Frame: 2 years ]
    Time from tisagenlecleucel infusion to first documented disease progression or death due to any cause
  • Overall survival (OS) [ Time Frame: 2 years ]
    Time from tisagenlecleucel infusion to death due to any cause
  • tisagenlecleucel transgene concentration [ Time Frame: 2 years ]
    Transgene concentration as detected by qPCR in target tissue
  • Cmax; cellular kinetic parameter of tisagenlecleucel [ Time Frame: 2 years ]
    The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (% or copies/ µg)
  • Tmax; cellular kinetic parameter of tisagenlecleucel [ Time Frame: 2 years ]
    The time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days)
  • AUC0-28; cellular kinetic parameter of tisagenlecleucel [ Time Frame: 2 years ]
    The AUC from time zero to day 28, in peripheral blood (%*days or days*copies/ µg)
  • AUC0-84d; cellular kinetic parameter of tisagenlecleucel [ Time Frame: 2 years ]
    The AUC from time zero to day 84, in peripheral blood (%*days or days*copies/ µg)
  • T1/2; cellular kinetic parameter of tisagenlecleucel [ Time Frame: 2 years ]
    The half-life associated with the elimination phase slope of a semi logarithmic concentration-time curve (days) in peripheral blood
  • Tlast; cellular kinetic parameter of tisagenlecleucel [ Time Frame: 2 years ]
    The last observed measureable timepoint after dose administration
  • Summary of exposure of CD3+ tisagenlecleucel cells in peripheral blood [ Time Frame: 2 years ]
    In vivo cellular kinetics of CD3+ tisagenlecleucel cells detected by flow cytometry
  • humoral immunogenicity [ Time Frame: 2 years ]
    Antibody titers specific to the tisagenlecleucel molecule prior to and following infusion.
  • cellular immunogenicity [ Time Frame: 2 years ]
    Presence of T lymphocytes activated by the tisagenlecleucel protein
  • Summary scores of PRO measured by SF-36v2 quality of life questionnaire [ Time Frame: 2 years ]
    Effect of tisagenlecleucel therapy on Patient reported outcomes
  • Summary scores of PRO measured by EQ-5D-3L quality of life questionnaire [ Time Frame: 2 years ]
    Effect of tisagenlecleucel therapy on Patient reported outcomes
  • Summary scores of PRO measured by FACT-Lym quality of life questionnaire [ Time Frame: 2 years ]
    Effect of tisagenlecleucel therapy on Patient reported outcomes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma
Official Title  ICMJE A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel (CTL019) in Adult Patients With Refractory or Relapsed Follicular Lymphoma
Brief Summary This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Follicular Lymphoma
Intervention  ICMJE Biological: tisagenlecleucel
single infusion
Study Arms  ICMJE Experimental: CTL019
tisagenlecleucel infusion
Intervention: Biological: tisagenlecleucel
Publications * Fowler NH, Dickinson M, Dreyling M, Martinez-Lopez J, Kolstad A, Butler J, Ghosh M, Popplewell L, Chavez JC, Bachy E, Kato K, Harigae H, Kersten MJ, Andreadis C, Riedell PA, Ho PJ, Pérez-Simón JA, Chen AI, Nastoupil LJ, von Tresckow B, Ferreri AJM, Teshima T, Patten PEM, McGuirk JP, Petzer AL, Offner F, Viardot A, Zinzani PL, Malladi R, Zia A, Awasthi R, Masood A, Anak O, Schuster SJ, Thieblemont C. Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial. Nat Med. 2022 Feb;28(2):325-332. doi: 10.1038/s41591-021-01622-0. Epub 2021 Dec 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 1, 2021)
97
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2018)
113
Estimated Study Completion Date  ICMJE May 22, 2025
Actual Primary Completion Date November 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A)
  • Radiographically measurable disease at screening

Exclusion Criteria:

  • Evidence of histologic transformation
  • Follicular Lymphoma Grade 3B
  • Prior anti-CD19 therapy
  • Prior gene therapy
  • Prior adoptive T cell therapy
  • Prior allogeneic hematopoietic stem cell transplant
  • Active CNS involvement by malignancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   France,   Germany,   Italy,   Japan,   Netherlands,   Norway,   Spain,   United Kingdom,   United States
Removed Location Countries Taiwan
 
Administrative Information
NCT Number  ICMJE NCT03568461
Other Study ID Numbers  ICMJE CCTL019E2202
2017-004385-94 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

URL: https://www.clinicalstudydatarequest.com
Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novartis Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP